Active not recruitingPHASE1INTERVENTIONAL

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

This is an early-stage medical study, called a Phase 1 trial, looking into a new treatment named Tuvusertib (M1774). Doctors are trying to find out how safe it is, what side effects it might cause, and how the body uses and gets rid of it. They are testing Tuvusertib on its own and also in combination with another drug called niraparib. This study is for people who have solid tumours that are advanced, meaning they have spread to other parts of the body (metastatic) or are too difficult to remove with surgery (unresectable). The aim is to understand these new treatments better and to see if there are any early hints that they might be effective in fighting these types of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

161

Start

20 Dec 2019

Estimated completion

30 Jul 2026

Metastatic or Locally Advanced Unresectable Solid Tumors

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first times a new drug is being tested in humans. The main goal at this stage is to check for safety, find the best dose, and understand how the drug works in the body. They call this 'first-in-human'. Researchers are looking at a drug called Tuvusertib (M1774). They'll be testing it by itself and also together with another cancer drug called niraparib.

The study is for people who have solid tumours that have either spread to other parts of the body (this is called metastatic) or are advanced and can't be removed by surgery. For these people, standard treatments might not have worked, or there might not be a usual treatment available that doctors think would help.

The information gathered from this study will help determine if Tuvusertib is safe enough to be tested in larger studies and if it shows any early promise in treating these types of cancers. It's an important step in developing new potential treatments.

Key takeaways

It's an early-stage study (Phase 1) mainly focused on safety.
It targets advanced solid tumours that have spread or can't be removed by surgery.
Researchers are testing a new drug, Tuvusertib (M1774), sometimes with another drug, niraparib.
You would have regular check-ups, blood tests, and scans.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would typically need to meet certain conditions. For example, you must have solid tumours that are advanced, meaning they’ve spread or doctors can't remove them with surgery, and standard treatments haven't worked or aren't suitable. You also need to be reasonably fit and able to carry out your daily activities without too much difficulty, as assessed by a doctor.

There are also some things that would mean you couldn't take part. This includes having recent major surgery, or if you still have severe side effects from previous cancer treatments that haven't improved. If you have active brain tumours that are causing symptoms or need steroid treatment, you would also not be able to join. Your doctor will carefully check all the requirements to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced solid tumours that have spread or cannot be surgically removed?
Has my current standard cancer treatment not worked, or is it not suitable for me?
Am I generally well enough to go about my daily activities?
Do I have any significant ongoing side effects from previous cancer treatments?
Have I had any recent major surgery (within the last 4 weeks)?
Do I have active or symptomatic brain tumours?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would regularly visit the clinic for check-ups and assessments. The study involves taking either the new drug Tuvusertib (M1774) on its own, or Tuvusertib together with another drug called niraparib. You would receive the medication according to a schedule set by the study doctors. These visits will include checks on your general health, blood tests (sometimes to see how the drug is handled by your body and how it affects your body), and scans to see how your tumour is responding. The total length of your participation would be discussed with you by the study team, but it would involve regular follow-up for a period of time.

Potential risks and benefits

Taking part in an early-stage study like this means there's a chance the treatment might not help your cancer, or it could cause new side effects. All new drugs have potential risks, and the study team will monitor you closely for any unwanted effects. However, if standard treatments haven't worked, this study offers the chance to try a new treatment that might potentially help. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Massachusetts General Hospital
Verified postcode
Boston, United States
NEXT Oncology
Verified postcode
Austin, United States
Mary Crowley Cancer Research Centers
Verified postcode
Dallas, United States
The Methodist Hospital Research Institute
Verified postcode
Houston, United States
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
Verified postcode
Houston, United States
Beijing Cancer Hospital
Verified postcode
Beijing, China
National Cancer Center Hospital - Dept of Experimental Therapeutics
Verified postcode
Chūōku, Japan
National Cancer Center Hospital East - Dept of Experimental Therapeutics
Unverified
Kashiwa-shi, Japan
Hospital Clinic de Barcelona - Servicio de Oncologia
Verified postcode
Barcelona, Spain
Hospital Universitari Vall d'Hebron - Oncology Dept.
Verified postcode
Barcelona, Spain
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Verified postcode
Madrid, Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Verified postcode
Valencia, Spain

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumours which have spread (metastatic) or cannot be removed by surgery (unresectable).

What are the new drugs being tested?

The new drug is called Tuvusertib (M1774). It's also being tested with an existing drug called niraparib.

Why is it called a 'Phase 1' study?

Phase 1 means it's an early-stage study, mainly focused on checking if the new drug is safe and finding the right dose in humans.

Will I get the new drug only, or a combination?

The study is testing Tuvusertib (M1774) alone and in combination with niraparib. Your doctor will explain which group you might be in.

Are there other treatment options available outside of this study?

Your doctor can discuss all available treatments for your condition, including standard options and other clinical trials, both inside and outside of this study.